MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751NAH
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pump passed the displacement test and self test.Unit received with motor error alarm during the basic occlusion test due to loose/flush drive support disk.Unable to perform the unexpected restart error test, prime/a33 test, excessive no delivery test, and occlusion test due to motor error alarm.Pump received with normal operating current.Pump passed off no power test.No unexpected low battery alarm anomalies noted, and no unexpected battery power loss anomalies noted.Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis, and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had motor error alarm.Customer was able to complete pump rewind.Customer did not report an motor position encoder error alarm.The customer stated that the drive support cap was normal.Customer stated that insulin pump had no delivery alarm.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10571650
• Report Number: 2032227-2020-180696
• Device Sequence Number: 3032890
• Product Code: OZO
• UDI-Device Identifier: 00643169503687
• UDI-Public: (01)00643169503687
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A4751NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 58